Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines.

The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. An authorized generic is used to describe an approved brand name drug ...

Generics (typically small molecules) and biosimilars (typically larger, more complex molecules) are approved through different abbreviated pathways that avoid duplicating certain costly clinical ...

Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. Learn about biosimilars and how they benefit patients.

Gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) FDA warns about serious breathing problems for … imaging Sept. 21, 2015 Ultram, Ultram ER, Conzip, and generics ...

This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications ...

In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally less expensive ...

GenericsGUIDANCE DOCUMENT Guidance for Industry 180-Day Exclusivity: Questions and Answers January 2017

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

93 first generics and 75+ original ANDAs approved under prioritized assessment of generic drug application submissions for COVID-19 108 pre-ANDA meeting requests answered